FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
K Number: K100610
·
Decision Jan 20, 2011
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
29
Review Days
323
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Basic Information
- Device Name
- LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
- K Number
- K100610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lutronic Corporation
- Date Received
- March 3, 2010
- Decision Date
- January 20, 2011
- Product Code
- ONG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
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| K213569 | HOLLYWOOD SPECTRA Laser System | Feb 4, 2022 | Substantially Equivalent |
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| K183566 | CLARITY II Laser System | Jun 14, 2019 | Substantially Equivalent |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Dec 10, 2018 | Substantially Equivalent |
| K173700 | PICOPLUS Laser System | Jun 19, 2018 | Substantially Equivalent |
| K171009 | LASEMD Laser System | Jun 23, 2017 | Substantially Equivalent |
| K163196 | ACTION II Laser System | May 24, 2017 | Substantially Equivalent |